Kornimate/medical-research-clean huggingface dataset:
intrathecal stem cells for cerebral palsy phase ii

Conditions: Cerebral Palsy

Summary: the purpose of this study is to determine whether the infusion of intrathecal autologous bone marrow total nucleated cells would improve the neurologic evolution of pediatric patients with quadriparetic cerebral palsy.

there is accumulated evidence that shows that the administration of bone marrow total nucleated cells (tnc) into the brain may produce some benefits by different mechanisms like cytokine production, in several neurological areas such as motor, social, adaptative and cognitive. it has been found that after introducing tnc in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be delivered more efficiently to the injured area, compared with intravenous route in patients with neurologic injury. patients will be stimulated for 3 consecutive days with subcutaneous granulocyte colony stimulating factor (g-csf) and then their bone marrow will be harvested according to their weight. bone marrow will be processed in order to obtain the buffy coat and minimize the amount of red blood cells. an inoculum of 10ml of this tnc will be infused intrathecally. patients will be evaluated with the "gross motor functional classification system" before the procedure and one, three and six months after that.

Eligibility criteria:
inclusion criteria: * patients with quadriplegic cerebral palsy, with an age from 7 to 9 years of age, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours exclusion criteria: * patients with neurodegenerative or autoimmune diseases * patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with g-csf or at the procedure * patients who do not sign the informed consent form

Keywords: brain children cerebral palsy bone marrow stem cells intrathecal autologous total nucleated cells quadriparesis
do biomarkers predict response to a pediatric chronic pain symptom management program?

Conditions: Irritable Bowel Syndrome; Functional Abdominal Pain Syndrome; Functional Gastrointestinal Disorders; Functional Bowel Disorder; Functional Abdominal Pain; Functional Abdominal Pain Disorders

Summary: the purpose of this study is find out if we can use simple tests (biomarkers) to tell us if a specific child would benefit most from cbt or from the low fodmaps diet.

aim 1: we will categorize children ages 7-12 yrs. of age with fgids (n=250) as to whether they have/do not have one or more of the following abnormal physiologic changes: a) autonomic nervous system imbalance as indicated by low heart rate variability; and/or (b) abnormalities in gut physiology: impaired gut barrier function (increased permeability); and/or increased abundance of species of gammaproteobacteria and/or clostridia; and/or gut neuroimmune dysfunction (increased fecal chromogranin a and secretogranin 2 concentrations). aim 2: children will be randomized to the two treatments most commonly used in clinical practice: cbt or a low fodmap diet for a 3-week treatment period. we will compare the response to the treatments in those with/without abnormal physiologic biomarkers at 3 weeks, 3 months, and 6 months.

Eligibility criteria:
inclusion criteria: * a child 7-12 years of age with a fgid will be recruited if the medical evaluation reveals no organic reason for the abdominal pain and the child has abdominal pain that meets the definition of a fgid (i.e., ibs, functional abdominal pain) according to the pediatric rome iii criteria (rome iv will be substituted when validated). parents and children must speak and understand english because of the psychological assessment and cbt requirements. exclusion criteria: * children who have: had past bowel surgery; documented gi disorders (e.g., crohn's disease); a serious chronic medical condition (e.g., diabetes); weight and/or height \< 2 sd for age; chronic conditions with gi symptoms (e.g., cystic fibrosis); autism spectrum disorder, significant developmental delay, psychosis, or a history of bipolar disorder; been treated with antibiotics/probiotics within 2 mo. (because of effects on gut microbiome analysis), and children who for some reason could not be randomized to the low fodmap diet.vegetarian; children who are currently on the fodmap diet or receiving cbt children who speak only spanish are not eligible because the rome questionnaire and psychological testing are not available in spanish. despite this, a large proportion of the children enrolled will be hispanic.
isolated roux loop pancreaticojejunostomy versus pancreaticogastrostomy after pancreaticoduodenectomy

Conditions: Pancreatic Fistula After Pancreaticoduodenectomy

Summary: pancreaticoduodenectomy (pd)is the treatment of choice for patients with periampullary tumour (benign or malignant). in the recent years, the mortality rate of pd has decreased to 5% in many centers. however, pancreatic fistula (popf) still occurs in 5 % to 40% of patients after pd. the hypothesis that isolated roux loop pj with isolated pancreatic drainage decrease the incidence of pf and severity with preservation of pancreatic function. so the investigators compare isolated roux loop pancreaticojejunostomy (pj) versus pancreaticogastrostomy (pg) as regards incidence of popf, severity of popf and functional outcome.

the hypothesis that isolated roux loop pj decrease the incidence of pf and severity with preservation of pancreatic function (exocrine and endocrine functions). preoperative evaluation included abdominal ct, liver function, tumor marker cea, ca19-9, preoperative ercp were optional in selected cases (patients with high bilirubin with high enzymes. patients with distant metastasis or locally advanced were excluded. informed consent was obtained from all patients entered in the study randomization: enrolled patients were randomized intraoperatively after pd resection to either isolated roux pj with isolated pancreatic drainage group or pg group by closed envelope which withdrawn by the nurse. operative technique. standard pd with regional lymphadenectomy was performed. pg was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa. isolated roux pj group, reconstruction was begun using the transected jejunum and, which was anastomosed in end to side fashion. a separate roux loop was performed for hj, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and gj was done in this loop (30 cm caudally from hj). the pj loop was anastomosed to the main loop (20 cm caudal to gj). one intrabdominal drains in morrison space. intraoperative data and postoperative data were collected. pancreatic function assessment. the primary outcome was assessment the incidence of popf after isolated roux pj and pg. the secondary outcomes were intraoperative blood loss, drain amount,day to resume oral intake hospital stay, operative duration, pancreatic function, postoperative complications delayed gastric emptying,

Eligibility criteria:
inclusion criteria: * all periampullary tumour either benign or resectable malignant tumour exclusion criteria: * locally advanced tumour infiltrating sma * metastasis * unfit

Keywords: periampullary tumour isolated roux loop pj pg
quality of life and sexuality in women with gynaecological cancer

Conditions: Cancer

Summary: patients with premalignant (cin3) and malignant cervical cancer will asked to complete questionnaires regarding intimacy (enrich) and life adaptation (pais) before treatment (surgery or radiotherapy) and after completion of treatment in order to estimate the influence of disease and treatment on quality of life indices.

no additional information. see above

Eligibility criteria:
inclusion criteria: * women with gynaecological cancer intended to undergo chemotherapy or surgery

Keywords: gynaecological cancer quality of life sexuality
compassionate use of opaganib in patients with coronavirus disease 2019 (covid-19)

Conditions: Coronavirus Infections

Summary: shaare-zedek medical center is a tertiary academic hospital in jerusalem, israel. on march 2020, a dramatic increase in the number of covid-19 cases were diagnosed in jerusalem. redhill biopharma, ltd. offered opaganib under compassionate use for the treatment of covid-19 patients. eligible patients were those hospitalized with covid-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. patients received opaganib and standard of care. for the purpose of this study, the opaganib and standard of care patient group was compared to a group of patients that received only standard of care. opaganib is an investigational drug under development and not approved for commercial distribution.

in this observational study, the two cohorts were assigned retrospectively. patients either received opaganib and standard of care (soc) or soc only. all patients were defined by the treating physicians at baseline as severe covid-19. for the control cohort, irb approval was granted to collect de-identified data. both cohorts had similar median age and similar rates of diabetes, hypertension and obesity. the two treatment groups, opaganib and soc vs. soc were then analyzed for their clinical outcomes including baseline characteristics.

Eligibility criteria:
inclusion criteria: * hospitalized patients with covid-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay * patients with severe disease requiring oxygen support via high-flow nasal cannula * signed informed consent * acceptable liver and renal function tests * acceptable hematologic status exclusion criteria: * pregnant or nursing women * patients on warfarin, apixaban, argatroban or rivaroxaban * patients with new york heart association class iii or iv cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ecg
physiological changes with high-flow nasal cannula

Conditions: Respiratory Distress Syndrome in Premature Infant

Summary: to measure changes in physiologic parameters in extremely low birthweight (elbw) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (ncpap).

after informed consent is obtained, eligible infants who are stable on ncpap therapy of 5-7 cm h20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. all subjects will have physiologic data and electrical impedance tomography collected at: 1. baseline ncpap for 15 minutes 2. upon transition to high flow nasal cannula at 8 lpm for 6 hours. data collection is obtained after infant is calm for 15 minutes at the beginning and end of this 6 hour period 3. then upon return to baseline ncpap for a final 15 minutes of data collection.

Eligibility criteria:
inclusion criteria: * 23 to 28+6 weeks gestational age at birth * corrected gestational age less than or equal to 30 weeks * over 72 hours of life * stable on nasal cpap of 5-7cm h20 * hemodynamically stable * tolerating routine handling * nares size appropriate for fisher \& paykel optiflow jr 2 hfnc size xs or small * successfully extubated for 12 hours after administration of surfactant * caffeine citrate at a maintenance dose of 5 to 10 mg /kg * transcutaneous monitoring in place * stable blood gas (ph\>/= 7.25 and paco2 \<60 mmhg torr) exclusion criteria: * prior pneumothorax or evidence of pulmonary interstitial emphysema. * prior or current pulmonary hemorrhage * congenital airway malformations * major cardiopulmonary malformations * congenital diaphragmatic hernia or untreated bowel obstruction * poor respiratory drive unresponsive to cpap therapy * requirement of a ncpap of \>8 cmh20 or fio2 \> 0.3 to maintain oxygen saturations between 90-95 percent. * receiving positive pressure breaths or sipap on prongs * conflicting clinical trial * clinically unstable per physician discretion

Keywords: high flow nasal cannula nasal cpap
evaluation of safety and efficacy of the flexstent® femoropopliteal self-expanding stent system

Conditions: Peripheral Artery Disease; Peripheral Vascular Disease; Vascular Disease; Cardiovascular Diseases; PAD

Summary: this is a clinical study of a new self-expanding stent (flexstent®) designed specifically to cope with the extreme demands of the superficial femoral artery (sfa)/proximal popliteal artery. the arteries are often abbreviated as femoropopliteal. the intent of this study is to demonstrate that the flexstent® femoropopliteal self-expanding stent system is safe and effective for the treatment of patients with peripheral arterial disease. specifically, the flexstent® shall meet or exceed the proposed safety and efficacy performance goals established for femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.


Eligibility criteria:
inclusion criteria: all subjects must meet the following criteria: 1. subjects, male or female, must be at least 35 years of age at the time of consent. a female of childbearing potential may be enrolled, provided she has a negative pregnancy test within 7 days of screening. 2. subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol. 3. rutherford classification category 2-4 4. de novo lesion in the femoropopliteal artery, including the entire extent of the superficial femoral artery and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint 5. disease segment length ≤ 180 mm 6. \>70% diameter stenosis and/or occlusion based on site-determined visual angiography 7. patent ipsilateral iliac artery 8. patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention 9. target reference vessel diameter 3.5-7.5 mm. 10. projected life expectancy of 12 months or greater 11. patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements 12. patient is willing and able to provide signed informed consent exclusion criteria: any subject meeting any of the following criteria will be excluded from the study. 1. target vessel previously treated with a stent 2. target lesion within 1.5 cm of the ostium of the sfa 3. rutherford classification category 0,1,5 or 6 4. inability to tolerate antithrombotic or antiplatelet therapies 5. pregnancy (female of child-bearing age confirmed pregnant) 6. other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up. 7. serum creatinine \> 2.5 mg/dl 8. myocardial infarction or stroke within 30 days of treatment date 9. known hypercoagulable state 10. known bleeding diathesis 11. untreated angiographically-evident thrombus in target vessel 12. patients currently enrolled in any other clinical trial

Keywords: flexstent superficial femoral artery or sfa self expanding stent stent bare metal stent
feasibility, safety and outcome of transrectal hybrid-notes anterior resection

Conditions: Sigmoid Diverticulosis; Sigmoid Diverticulitis; Colon Adenoma; Rectal Prolapse

Summary: natural orifice transluminal endoscopic surgery has become an important topic. notes access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such notes procedures are feasible and safe. the complication rate to conventional laparoscopic procedures is similar. since transvaginal access is impossible in men, an alternative route is missing. there are experimental studies and small case series reporting the feasibility of transrectal anterior resection. however any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. this study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-notes anterior resection.

primary endpoint: to demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to clavien-dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-notes transrectal anterior resection for benign indication in men and women. secondary endpoints: * quality of life 6 months after surgery * continence 6 months after surgery * pain postoperative * complication rate * duration of procedure * lengh of stay hypothesis: the investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed). study design: this is an open cohort study on 60 patients. the patients are included before surgery and baseline parameters are put in a registry. there are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed. inclusion criteria: - benign indication for left sided colectomy. exclusion criteria: * age \<18 years * patient unable to understand informed consent or missing informed consent * emergency surgery power calculation: a feasibility of 80% with a precision of 15% is estimated. given a 5% drop out rate 36 patients are to be included in the study.

Eligibility criteria:
inclusion criteria: * benign indication for left sided colectomy exclusion criteria: * age below 18 years * unable to understand informed consent of missing informed consent * emergency surgery
the effects of schroth based exercise therapy in adolescents with pectus excavatum

Conditions: Pectus Excavatum; Pectus Excavatum Deformity; Funnel Chest; Chest Deformities

Summary: research on exercise methods for pectus excavatum (pe) is limited, highlighting the need for further studies. this study investigated the effects of schroth-based exercise therapy combined with vacuum treatment in 35 adolescents with pe, divided into a vacuum + exercise group (n=19) and a vacuum-only group (n=16). outcomes included deformity severity, sagittal posture, thoracic cage and spinal mobility, muscle endurance, and quality of life. the combination therapy significantly improved sagittal spinal posture (craniovertebral, thoracic, thoracolumbar, lumbar angles) and deformity-specific quality of life (nuss questionnaire scores) compared to vacuum-only treatment.


Eligibility criteria:
inclusion criteria: * having pectus excavatum * being 10-18 years * having haller index more than 2.5 exclusion criteria: * individuals with pectus excavatum associated with a syndrome individuals with mixed deformity * individuals who have previously received any conservative treatment or surgery for chest deformity or spinal issues * individuals with neuromuscular, rheumatic, or chronic systemic diseases

Keywords: funnel chest pectus excavatum exercise exercise therapy vacuum tissue expansion devices
deboxa for inoperable net liver metastases

Conditions: Neuroendocrine Tumors; Neoplasm Metastasis; Liver

Summary: a prospective clinical trial to study the safety and effectiveness of transcatheter artery chemotherapy and embolization (tace) using callispheres drug-eluting beads with oxaliplatin (deboxa) in treating patients who have inoperable neuroendocrine neoplasm (nen) liver metastases.

objectives: i. determine the safety and effectiveness of transcatheter artery chemotherapy and embolization (tace) using callispheres drug-eluting beads with oxaliplatin (deboxa) in patients with inoperable neuroendocrine neoplasm (nen) liver metastases. ii. determine the response rate (rr) of intrahepatic lesions in patients treated with this regimen. iii. determine the overall survival (os), progression-free survival time (dfs), time to hepatic progression (thp), and quality of life (qol) in patients treated with this regimen. iv. safety assessment: adverse events (aes) and severe adverse events(saes) outline: this is a single-arm, multi-center, prospective study. patients receive d-tace. embolization agent: callispheres drug-eluting beads. chemotherapy agent: oxaliplatin. treatment repeats every 5 weeks in the absence of progression of hepatic lesions, or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * diagnosis is confirmed by biopsy or clinical data, primary site is resected or primary site is not resected but without risks of bleeding, obstruction in the near future. * failure of ≥ 1 system treatment, such as long-acting somatostatin or ep chemotherapy regimen. * standard surgical resection can not be performed because of extent liver involvement （liver involvement ≥ 2 lobes or ≥ 2 major vessels）, or patients who are not willing to accept surgical operation. * predicted survival \>3 months. * child pugh score: ≤ 7 * ecog score for performance status: 0-1 * informed consensus is achieved. exclusion criteria: * metastases to other organs or sites besides liver. * prior tace for liver tumors in 1 year. * obvious hepatic arterio-venous shunt or arterio-portal shunt. * prior or concurrent malignancy (except basal carcinoma or squamous carcinoma of skin or carcinoma in situ of cervex uteri which has been cured). * platelet count \< 50,000/mm\^3 or white blood cell count \<3,000 /mm\^3 without hypersplenism. * creatinine greater than upper limit of normal (uln) * ast or ast \> 5 times uln * compromised coagulation: inr (international normalised ratio) \>1.5, current anti-coagulation therapy or hemorrhagic disorders. * history of severe diseases involving heart, kidney, marrow, lung or central neural system. * infection diseases which need antibiotics treatment before less than 1 month. * co-existing morbidity or social environment which may lead patients not to obey study protocol or threat patients' safety.

Keywords: tace oxaliplatin
photoacoustic imaging in detecting ovarian or fallopian tube cancer

Conditions: Fallopian Tube Carcinoma; Ovarian Carcinoma

Summary: this pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian or fallopian tube cancer. photoacoustic imaging is an imaging method that uses lasers to light up tissue, and then converts the light information into ultrasound images. photoacoustic imaging can provide images of the structure of tissues, as well as their function and the levels of molecules, such as the flow of blood in blood vessels and the level of oxygen in the blood. photoacoustic imaging may help doctors determine whether a mass is benign (non-cancerous) or cancerous based on the molecular differences between cancer and normal tissue. it may be more accurate and less expensive than other imaging methods, and does not expose patients to radiation.

primary objectives: i. to assess the performance of photoacoustic imaging (pai) in detection of ovarian cancer in a clinical setting and to help improve the design of the next generation hand held pai probe. secondary objectives: i. to evaluate vasculature and oxygen saturation in lesions based on pai-measurements. outline: patients undergo pai over 15-30 minutes prior to the ovarian excision.

Eligibility criteria:
inclusion criteria: * patients must be undergoing ovarian resection * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients who have had primary surgical excision * pregnant or lactating women